MAUDE Adverse Event Report: SYNTHES ELMIRA 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION; PLATE, FIXATION, BONE

Catalog Number VPT4010.20

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Failure of Implant (1924)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: after a mandibular fracture the pet was treated with a unilocl-plate on (b)(6) 2015.On (b)(6) 2015 it was detected that the plate was deformed and the fracture was reopened.After the revision on (b)(6) 2015 the plate was bent on place.An additional plate was inserted.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Device is a veterinary product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Based on sales data the subject device may belong to one of three lot numbers.These lot numbers are: 6879886, 7909679 and 9883893.The subject device has been received and is currently in the evaluation process.Device history record reviews were performed for the three possible subject device lots.The results of these reviews are as follows: manufacturing location: (b)(4).Manufacturing date: 27-feb-2012.Part #: vpt4010.20, lot#: 6879886 (non-sterile) - 2.0mm ti mini locking plate 20 holes/adaption.Lot was release to the warehouse on 27-feb-2012.Work order no: (b)(4) was released on 10-feb-2012 for qty: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4).Manufacturing date: 30-jan-2015 part #: vpt4010.20, lot#: 7909679 (non-sterile) - 2.0mm ti mini locking plate 20 holes/adaption.Lot was release to the warehouse on 30-jan-2015.Work order no: (b)(4) was released on 21-jan-2015 for qty: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4).Manufacturing date: 25-aug-2015 part #: vpt4010.20, lot#: 9883893 (non-sterile) - 2.0mm ti mini locking plate 20 holes/adaption.Lot was release to the warehouse on 25-aug-2015.Work order no: (b)(4) was released on 17-aug-2015 for qty: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Clarification: the exact date of device malfunction is unknown; however, the issue was discovered on (b)(6) 2015.Three potential udi numbers exist given the three possible lot numbers for the device.(b)(4).Manufacturing investigation evaluation: one (1) 2.0mm locking plate was received in a slightly bent condition.On (b)(6) 2015, a fracture of the mandibula was treated with a plate.During a follow up control on (b)(6) 2015, the loss of the reposition was found.A revision surgery was performed on (b)(6) 2015.The intact plate was left in place, but bent back in situ to fit the mandibula anatomically correct.The fracture was then stabilized with an additional plate.Based on the studies carried out, it is likely that the first plate could not withstand the occurring load which ultimately led to the loss of reduction and subsequently to the jaw inconsistency.Postoperative activities of the cat may have played a certain role, too.No indication for material, manufacturing, or design related issues were found.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM TI MINI LOCKING PLATE 20 HOLES/ADAPTION
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4840382
• MDR Text Key: 5914486
• Report Number: 2520274-2015-14413
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPT4010.20
• Device Lot Number: 6879886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1